Examination of Witnesses (Questions 1200
- 1219)
WEDNESDAY 8 DECEMBER 2004
DR RICHARD
KENNEDY, PROFESSOR
ALLAN TEMPLETON
AND PROFESSOR
LESLEY REGAN
Q1200 Dr Harris: I think it is in
its remit.
Professor Regan: It is very important.
Q1201 Dr Harris: Can you be a bit
more specific then?
Professor Regan: It comes back
to how your unit is assessed and where your clients come from,
or your patients come from (whichever way you wish to look at
it). At the end of the day, if you are given a sheet of paper
and you say, "I wish to access in-vitro fertilisation and
I am looking for the best place to go", and you look at the
pregnancy rate per transfer you will get very different information
than if you were to look at what were the successful pregnancy
outcomes from that clinic. What we know is that there are higher
pregnancy rates per transfer, it is thought, with multiple embryo
transfer or two or three transfers.
Professor Templeton: May I just
say, in relation to this table, there are major reservations about
data collection in some of the countries that are well above the
United Kingdom. The denominator is a key issue. But if you look
at singleton births, even somewhere as far ahead, apparently,
of the United Kingdom as the US, the rates are the same.
Q1202 Chairman: Are you saying that
the data collection is rubbish in this country?
Professor Templeton: Not in this
country. It is the denominator data. In this country, as soon
as an injection of gonadatrophine begins that cycle is registered.
We think, probably, most are.
Q1203 Chairman: So your defence about
the league table is other countries do it badly?
Professor Templeton: No, I am
just saying that in certain other countries—and I would
not want to name them—above the United Kingdom there, we
know that data collection is confined to one or two clinics, and
that still it is voluntary, so that the clinics do not have to
submit their data.
Q1204 Dr Harris: Is Sweden one of
those countries?
Professor Templeton: No, no. Sweden
is certainly not one of those countries.
Q1205 Mr Key: Is it Iceland?
Professor Templeton: It is none
of the Scandinavian countries.
Q1206 Mr Key: So it is Greece? And
Russia and Slovenia? On this point about funding, if you look
at pregnancy rates per transfer in this table within the United
Kingdom there are also enormous discrepancies between different
IVF centres funding in different ways. Have you any evidence that
the way in which the clinics are funded makes a difference? For
example, quite a lot of the IVF clinics which are within NHS hospital
premises are actually privately owned by companies which set up
to specialise in this area, and the contract may or may not be
with the hospital trust. Is there any evidence that that makes
any difference, or accounts for the discrepancy?
Dr Kennedy: I think it is quite
clear, if we remove the commercialisation of IVF in this country,
which undoubtedly has driven practice, and the league tables that
have been produced, then we can move very quickly to more sensible
clinical practice which is not driven by this desire to be up
there in the league table but is there to serve our patients best,
to reduce the adverse consequences (ie, multiple pregnancy) and
to move to single embryo transfer in selective cases.
Q1207 Dr Iddon: Professor Templeton,
you or your organisation believe that the media and equipment
used in IVF, particularly when new materials are introduced, should
be regulated in some way. Who do you think should carry out that
regulation?
Professor Templeton: I think,
again, it is the accreditation system, and I think that the standards
set by the laboratory organisations in the context of assessing
new media, and so on, should be set down in the accreditation
system. So I think it should be done at that level; I do not think
it is a matter for legislation, it is a matter for the code of
practice or the accreditation system.
Q1208 Dr Iddon: I am sorry, could
I just be clear about who sets this code of practice? Your professional
organisation?
Professor Templeton: We would
be very happy to contribute to such a code. If we were asked then
I think the professional organisations could certainly evolve
a code of practice by which clinics in this country could be accredited.
Q1209 Chairman: If you were not asked,
would you trust it?
Professor Templeton: It would
depend on who was doing it, I guess.[2]
Q1210 Chairman: Is this a moral or
ethical judgment?
Professor Templeton: If you look
at the present code of practice (I forget how many there are)
there are six pages referring to counselling, and when I joined
the HFEA in 1995 I was astonished that there was about half-a-page
which referred to actual clinical practice in relation to egg
recovery. At that time there were two recorded deaths in Greece
from monitored egg recovery and yet there was nothing in the code.
So there were distortions within the code of practice which referred
to the origins of the HFEA. One of them was this overly need for
counselling and the other was the welfare of the child assessment,
with insufficient on clinical and laboratory standards of practice.
Q1211 Dr Iddon: There are some clinicians
who believe that success rates may be improved by using techniques
like assisted hatching and blastocyst transfer. There are other
clinicians who believe that that is of little benefit. What is
the view of the College?
Professor Templeton: The NICE
guidelines reviewed both of these issues and the jury, I think,
is certainly out on assisted hatching, but the overall indications
from the evidence that can be gathered is that there is not major
advantage. There may be subsections of patients but it has never
been shown in these subsections that it is unquestionably efficacious.
So I think there is an issue there. We have got bodies in this
country that have the ability: NICE has two processes, it has
the guidelines process and it has the HFEA process, and if we
are unsure about new technologies they can be assessed in that
way. You do not need specific organisations as such to do it;
I think it is part of medical practice.
Professor Regan: Could I just
add, at this point, that the examples you cited were all to do
with an IVF unit and the embryo transfer procedures. There are
a limited number of units within the United Kingdom that are using
multiple forms of additional therapies in order to improve, supposedly,
pregnancy rates, none of which have been demonstrated in any randomised
controlled trial to be of benefit and most of which, potentially,
have very significant side-effects for the woman who has been
given these medications. They include steroids, intravenous immunoglobin
infusions, aspirin, heparin injections and a variety of other
medications. It would be very helpful, I think, for the future
if we were to consider these issues as well as those that are
confined to an embryo and laboratory scenario, because they do
have very, very significant implications. It is quite horrifying,
I think, how many couples are advised to take these treatments
because they are desperate and because they have no other way
of knowing whether they should or should not, and they turn to
the internet, which, as you will recognise, does not have peer
reviewed information.
Q1212 Dr Iddon: Do you think the
present Act and/or the HFEA itself inhibits developments in clinical
practice like the ones I have just mentioned?
Professor Templeton: The only
example I know where I think, in my view, there have been inappropriate
inhibitions has been egg freezing. There has been an issue to
do with safety and efficacy of egg freezing and certainly there
was a very negative view taken by the then New Technology Committee
of the HFEA. However, by and large, the look at new practice has
been fair and has been balanced. You could say, of course, that
had ICSI not been so well developed and carefully developed in
Belgium we might still be talking about whether it was an appropriate
thing to do in this country, and there is an issue there, but
by and large I think new clinical developments are available in
this country. Just compare with some other European countries
where embryo freezing is not available, where PGD is not available,
where ICSI even now is not available; I think the relevant new
developments, by and large, have been made available.
Q1213 Chairman: Is there not an international
standards accreditation process?
Professor Templeton: Not to my
knowledge.
Q1214 Chairman: ISO?
Professor Templeton: No.
Dr Kennedy: If you are talking
about standard clinical practice, then the EU Directive will move
us in that direction, very much so.
Q1215 Chairman: So your view is that
it has not even started yet?
Dr Kennedy: It is starting but
the EU Directive will not be applicable to United Kingdom centres
until April 2006.
Q1216 Dr Harris: Professor Templeton,
do you think the Whittakers would agree with you that the HFEA—of
which you are a member?
Professor Templeton: Was, yes.
Q1217 Dr Harris: Maybe you were involved
in this decision. If so, please let me know. Do you think they
would agree that the HFEA, other than in egg freezing, has not
held back therapeutic advances?
Professor Templeton: That is a
difficult point, you would have to agree—very difficult.
They would probably disagree but others still have their reservations
about whether it is an appropriate way forward.
Q1218 Dr Harris: Yes, but the HFEA
told us that they changed their mind on that on the basis of scientific
advance between the first decision and this decision.
Professor Templeton: And they
changed their mind on Diane Blood as well.
Q1219 Dr Harris: Do you think science
changed around the safety of PGD between the fist decision and
the second decision, or was it the legal judgment that changed
in the Court of Appeal on the Hashmi case?
Professor Templeton: These are
external influences that obviously make people change their minds,
and that is all part of the richness of the discussion. It is
unfortunate that individual patients are caught up in that decision—Diane
Blood having to go abroad for her treatment and the Whittakers
not getting treatment but another group getting it—but it
is all part of that discussion and it should not be a static discussion.
2 Note by Dr Kennedy: The British Fertility
Position is that the code of practice/clinical standards could
be produced by the Professional Societies/relevant Royal College's.
The imminent EU Directive will require a "quality standard"
and a multidisciplinary group recently produced a draft quality
standard for assisted reproduction units in the UK. Back
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